HIV Testing Strategies in the Perinatal Setting

Approximately 40% of HIV-infected infants in the United States in 2000 were born to women not diagnosed with their HIV prior to delivery. (1) There are now effective medical therapies to prevent perinatal transmission, including anti-retroviral therapy, but this requires diagnoses of maternal HIV prior to delivery. Both the Centers for Disease Control and Prevention (CDC) and Institute of Medicine (IOM) have published strong recommendations for universal HIV-antibody testing of pregnant women.

This will be a randomized controlled, non-inferiority trial comparing two HIV testing strategies among English and Spanish-speaking patients presenting for prenatal care at SFGH WHC over the course of approximately one year. Eligible participants will be randomized by study personnel to either standard HIV counseling and testing (control arm) or abbreviated counseling and testing (study arm). Participants will receive a standard prenatal HIV testing brochure, undergo one of two HIV counseling/testing strategies, submit blood for an HIV-1 antibody test, and will follow-up with their medical provider for HIV test results. Upon completion of counseling, participants will undergo a short, structured (Pre-test) questionnaire administered by study staff. Following testing and receipt of results, participants will complete a second (Post-test) structured questionnaire administered by study staff.

Eligible women presenting to SFGH physician or midwife prenatal clinics will be recruited, consented and randomized by study staff to either the standard or abbreviated testing strategy. The outcomes studied will be patient satisfaction and the proportion of study participants who undergo HIV testing. Potential confounder variables to be measured will include demographic characteristics, prior HIV testing history, knowledge about HIV/AIDS, attitudes towards HIV testing, HIV test result, and type of provider (physician versus midwife).

• HIV Infections
• Pregnancy Related

• Experimental: Abbreviated Consenting
  Intervention: Procedure: Abbreviated HIV test counseling
• No Intervention: Standard Consenting

• Rapid HIV testing of women in labor and delivery: www.cdc.gov/hiv/pubs/rt-women.htm: Centers for Disease Control and Prevention: Divisions of HIV/AIDS Prevention, 2002.
• Sambamoorthi U, Akincigil A, McSpiritt E, Crystal S. Zidovudine use during pregnancy among HIV-infected women on Medicaid. J Acquir Immune Defic Syndr. 2002 Aug 1;30(4):429-39.
• Centers for Disease Control and Prevention (CDC). From the Centers for Disease Control and Prevention. Progress toward elimination of perinatal HIV infection--Michigan, 1993-2000. MMWR Morb Mortal Wkly Rep. 2002 Feb 8;51(5):93-7.
• Kalish LA, Pitt J, Lew J, Landesman S, Diaz C, Hershow R, Hollinger FB, Pagano M, Smeriglio V, Moye J. Defining the time of fetal or perinatal acquisition of human immunodeficiency virus type 1 infection on the basis of age at first positive culture. Women and Infants Transmission Study (WITS). J Infect Dis. 1997 Mar;175(3):712-5.
• Newell ML. Mechanisms and timing of mother-to-child transmission of HIV-1. AIDS. 1998 May 28;12(8):831-7. Review.
• Frenkel LM, Cowles MK, Shapiro DE, Melvin AJ, Watts DH, McLellan C, Mohan K, Murante B, Burchett S, Bryson YJ, O'Sullivan MJ, Mitchell C, Landers D. Analysis of the maternal components of the AIDS clinical trial group 076 zidovudine regimen in the prevention of mother-to-infant transmission of human immunodeficiency virus type 1. J Infect Dis. 1997 Apr;175(4):971-4.
• Shapiro DE, Tuomala R, Samelson R, et al. Mother-to-Child HIV Transmission Rates According to Antiretroviral Therapy, Mode of Delivery, and Viral Load (PACTG 367): Abstract #114. 9th Conference on Retroviruses and Opportunistic Infections. Seattle, WA, 2002.
• Phillips KA, Bayer R, Chen JL. New Centers for Disease Control and Prevention's guidelines on HIV counseling and testing for the general population and pregnant women. J Acquir Immune Defic Syndr. 2003 Feb 1;32(2):182-91.
• Centers for Disease Control and Prevention. Revised recommendations for HIV screening of pregnant women. MMWR Recomm Rep. 2001 Nov 9;50(RR-19):63-85; quiz CE1-19a2-CE6-19a2.
• Centers for Disease Control and Prevention (CDC). HIV testing among pregnant women--United States and Canada, 1998-2001. MMWR Morb Mortal Wkly Rep. 2002 Nov 15;51(45):1013-6.
• CDC. Progress Toward Elimination of Perinatal HIV Infection - Michigan, 1993-2000. MMWR 2002;51.
• Centers for Disease Control and Prevention (CDC). Advancing HIV prevention: new strategies for a changing epidemic--United States, 2003. MMWR Morb Mortal Wkly Rep. 2003 Apr 18;52(15):329-32.
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• Walmsley S. Opt in or opt out: what is optimal for prenatal screening for HIV infection? CMAJ. 2003 Mar 18;168(6):707-8. Review.
• Stringer EM, Stringer JS, Cliver SP, Goldenberg RL, Goepfert AR. Evaluation of a new testing policy for human immunodeficiency virus to improve screening rates. Obstet Gynecol. 2001 Dec;98(6):1104-8.
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• Cohan D, Gomez E, Greenberg M, Washington S, Charlebois ED. Patient perspectives with abbreviated versus standard pre-test HIV counseling in the prenatal setting: a randomized-controlled, non-inferiority trial. PLoS One. 2009;4(4):e5166. doi: 10.1371/journal.pone.0005166. Epub 2009 Apr 15.

Inclusion Criteria:

• Women 16 years of age or above seeking prenatal care at San Francisco General Hospital

Exclusion Criteria:

• Women who do not speak Spanish or English
• Women younger than 16 years of age
• Women who obtained an HIV test during the index pregnancy prior to initiation of prenatal care at SFGH
• Women known to be infected with HIV at initiation of prenatal care at SFGH